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Am J Kidney Dis. 2017 Oct;70(4):464-475. doi: 10.1053/j.ajkd.2016.11.029. Epub 2017 Feb 24.

Developing a Set of Core Outcomes for Trials in Hemodialysis: An International Delphi Survey.

Author information

1
Sydney School of Public Health, University of Sydney, Sydney, NSW, Australia; Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, NSW, Australia. Electronic address: nicole.evangelidis@sydney.edu.au.
2
Sydney School of Public Health, University of Sydney, Sydney, NSW, Australia; Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, NSW, Australia.
3
Departments of Medicine and Community Health Sciences; Libin Cardiovascular Institute and O'Brien Institute of Public Health, University of Calgary, Calgary, Canada.
4
Centre for Nephrology, University College London, London, United Kingdom.
5
Department of Medicine, University of Ottawa, Ottawa, Canada.
6
Crowe Associates, Oxon, United Kingdom.
7
PKD International, Geneva, Switzerland.
8
Renal Division, Ghent University Hospital, Ghent, Belgium.
9
Selzman Institute for Kidney Health, Section of Nephrology, Baylor College of Medicine, Houston, TX.
10
Sydney School of Public Health, University of Sydney, Sydney, NSW, Australia; Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, NSW, Australia; INSERM, U1153, Paris, France; Department of Nephrology and Clinical Immunology, University Hospital of Tours, Tours, France.
11
Department of Renal Medicine, Salford Royal NHS Foundation Trust, Salford, United Kingdom.
12
Queensland School of Medicine, University of Queensland at Princess Alexandra Hospital; Translational Research Institute; Metro South and Ipswich Nephrology and Transplant Services (MINTS), Princess Alexandra Hospital, Brisbane, Australia.
13
Renal Division, Kolling Institute, Sydney, Australia.
14
Centre for Transplantation and Renal Research, The Westmead Institute for Medical Research, University of Sydney, Westmead, New South Wales, Australia.
15
Division of Nephrology, University of California, San Diego, CA; Division of Preventive Medicine, University of California, San Diego, CA.
16
Arbor Research Collaborative for Health, Ann Arbor, MI.
17
University Hospital Geelong, Geelong, Australia.
18
Monash Medical Centre and Monash University, Clayton, Australia; Department of Epidemiology & Preventative Medicine, Monash University, Clayton, Australia.
19
Concord Clinical School, The University of Sydney, Sydney, Australia.
20
Monash Medical Centre and Monash University, Clayton, Australia.
21
Central Northern Adelaide Renal and Transplantation Service, Royal Adelaide Hospital, Adelaide, Australia; Faculty of Health Science, University of Adelaide, Adelaide, Australia.
22
Sydney School of Public Health, University of Sydney, Sydney, NSW, Australia.

Abstract

BACKGROUND:

Survival and quality of life for patients on hemodialysis therapy remain poor despite substantial research efforts. Existing trials often report surrogate outcomes that may not be relevant to patients and clinicians. The aim of this project was to generate a consensus-based prioritized list of core outcomes for trials in hemodialysis.

STUDY DESIGN:

In a Delphi survey, participants rated the importance of outcomes using a 9-point Likert scale in round 1 and then re-rated outcomes in rounds 2 and 3 after reviewing other respondents' scores. For each outcome, the median, mean, and proportion rating as 7 to 9 (critically important) were calculated.

SETTING & PARTICIPANTS:

1,181 participants (202 [17%] patients/caregivers, 979 health professionals) from 73 countries completed round 1, with 838 (71%) completing round 3.

OUTCOMES & MEASUREMENTS:

Outcomes included in the potential core outcome set met the following criteria for both patients/caregivers and health professionals: median score ≥ 8, mean score ≥ 7.5, proportion rating the outcome as critically important ≥ 75%, and median score in the forced ranking question < 10.

RESULTS:

Patients/caregivers rated 4 outcomes higher than health professionals: ability to travel, dialysis-free time, dialysis adequacy, and washed out after dialysis (mean differences of 0.9, 0.5, 0.3, and 0.2, respectively). Health professionals gave a higher rating for mortality, hospitalization, decrease in blood pressure, vascular access complications, depression, cardiovascular disease, target weight, infection, and potassium (mean differences of 1.0, 1.0, 1.0, 0.9, 0.9, 0.8, 0.7, 0.4, and 0.4, respectively).

LIMITATIONS:

The Delphi survey was conducted online in English and excludes participants without access to a computer and internet connection.

CONCLUSIONS:

Patients/caregivers gave higher priority to lifestyle-related outcomes than health professionals. The prioritized outcomes for both groups were vascular access problems, dialysis adequacy, fatigue, cardiovascular disease, and mortality. This process will inform a core outcome set that in turn will improve the relevance, efficiency, and comparability of trial evidence to facilitate treatment decisions.

KEYWORDS:

Delphi survey; Hemodialysis (HD); Standardized Outcomes in Nephrology-Hemodialysis (SONG-HD); biochemical end point; cardiovascular disease (CVD); core outcome set; dialysis adequacy; lifestyle-related outcomes; mortality; outcome domains; outcomes; patient-centered care; quality of life; research priorities; surrogate end points; trials; vascular access problems; well-being

PMID:
28238554
DOI:
10.1053/j.ajkd.2016.11.029
[Indexed for MEDLINE]

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